Myopia, ProgressiveNCT05939882
Low Concentration Atropine in the Prevention of Myopia in Children.
A study testing low concentration atropine (0.01%), low concentration atropine (0.02%) and low concentration atropine (0.04%) in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- low concentration atropine (0.01%), low concentration atropine (0.02%) and low concentration atropine (0.04%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 428 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The age of the screening stage is 6-9 years, both sexes;
- One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
- At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
- Parents have signed informed consent and agree to participate in screening and follow-up.
Who cannot join
- Parents disagree to sign the informed consent;
- Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
- Presence of other eye or systemic diseases;
- Allergies to low concentration atropine or sulfuric acid drugs;
- Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
- Presence of other situations that the researchers think is not appropriate for patients to be included in the project.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangui He
Shanghai, Shanghai Municipality, 200040
Xiangui He, MD, +8615000755422, xianhezi@163.com
About this study
Official title: A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
Read the detailed description
The main questions this double-blind, randomized controlled clinical study aims to answer are:
- To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
- To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.
Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
- Conditions
- Myopia, Progressive
- Being tested
- low concentration atropine (0.01%), low concentration atropine (0.02%), low concentration atropine (0.04%), Placebo
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low concentration atropine (0.01%)Drug
low concentration atropine (0.01%)
low concentration atropine (0.02%)Drug
low concentration atropine (0.02%)
low concentration atropine (0.04%)Drug
low concentration atropine (0.04%)
PlaceboDrug
Placebo eye drop
| Study group | Role | What they receive |
|---|---|---|
| 0.01% atropine | Experimental | 0.01% atropine eye drop Receives: Drug: low concentration atropine (0.01%) |
| 0.02% atropine | Experimental | 0.02% atropine eye drop Receives: Drug: low concentration atropine (0.02%) |
| 0.04% atropine | Experimental | 0.04% atropine eye drop Receives: Drug: low concentration atropine (0.04%) |
| placebo | Placebo comparator | placebo eye drop Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Myopia
Effectiveness Evaluation
Measured: 1 year
Secondary outcomes (4)
Changes in SE (after cycloplegia)
Effectiveness Evaluation
Measured: 1 year
Changes in AL
Effectiveness Evaluation
Measured: 1 year
Changes in visual acuity
Effectiveness Evaluation
Measured: 1 year
Changes in Choroidal Thickness
Effectiveness Evaluation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Apr 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Xiangui, Study director, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939882
- Sponsor's protocol ID
- jafakfakfa
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Controlled Study of Low Concentration Atropine in the Prevention of Myopia in Pre-myopia Children.
- ClinicalTrials.gov ID
- NCT05939882
- Acronym / sponsor ID
- jafakfakfa
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.
Detailed description
The main questions this double-blind, randomized controlled clinical study aims to answer are:
- To evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children.
- To evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression.
Patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. Patients are required to use the eye drops every night for one year and record after daily usage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.01% atropine | Experimental | Drug: low concentration atropine (0.01%)0.01% atropine eye drop |
| 0.02% atropine | Experimental | Drug: low concentration atropine (0.02%)0.02% atropine eye drop |
| 0.04% atropine | Experimental | Drug: low concentration atropine (0.04%)0.04% atropine eye drop |
| placebo | Placebo comparator | Drug: Placeboplacebo eye drop |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The age of the screening stage is 6-9 years, both sexes;
- One eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50D and +0.75D, the astigmatism was ≥-1.50D, and the best corrected far vision was at least 1.0;
- At least one of parents suffers from myopia (SE of at least one eye <=-3.00D);
- Parents have signed informed consent and agree to participate in screening and follow-up.
Key exclusion criteria (6 listed)
- Parents disagree to sign the informed consent;
- Presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery;
- Presence of other eye or systemic diseases;
- Allergies to low concentration atropine or sulfuric acid drugs;
- Histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low concentration atropine (0.01%)low concentration atropine (0.01%) | Drug | 0.01% atropine |
| low concentration atropine (0.02%)low concentration atropine (0.02%) | Drug | 0.02% atropine |
| low concentration atropine (0.04%)low concentration atropine (0.04%) | Drug | 0.04% atropine |
| PlaceboPlacebo eye drop | Drug | placebo |
Primary outcome
Cumulative Incidence of Myopia
Time frame: 1 year
Effectiveness Evaluation
4 secondary outcomes
Changes in SE (after cycloplegia)
Time frame: 1 year
Changes in AL
Time frame: 1 year
Changes in visual acuity
Time frame: 1 year
Changes in Choroidal Thickness
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Xiangui study director
Shanghai Eye Disease Prevention and Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low concentration atropine (0.01%), low concentration atropine (0.02%) and low concentration atropine (0.04%) in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangui He (+8615000755422, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Myopia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.